HRS in San Diego, our 46th annual meeting of the Heart Rhythm Society. This session is high-impact science, innovations in atrial fibrillation, ablation. We have a lot of great speakers for you. You're in for a treat. Please download the mobile app if you haven't already so you can participate and ask questions. And we will do our best to try and stay on time so there's an opportunity for these. Without further ado, I'm gonna introduce myself, Dr. Cara Pellegrini from UCSF and the San Francisco VA, my co-chair. Samir Saba, University of Pittsburgh. Fantastic, and then moving on, I'd like to introduce Dr. Monica Lowe. She'll be speaking to us about acute safety and effectiveness of a novel balloon-based PFA catheter in paroxysmal and persistent atrial fibrillation, acute results of the VOLT-AF IDE trial. Thank you, Monica. Thank you. Thank you, chairs and the abstract committee. It's my pleasure to review the acute results of the VOLT-AF IDE trial. The VOLT is a balloon in basket design and it has eight splines and it can give basically contact information, feedback in real time. It could be used for pacing, mapping, as well as delivery of PF. And it is steerable as well, so it can go through the Agileus sheath, that is, we're all very familiar with. In this case, it's a 13-front sheath. And it can also basically, the balloon technology focuses the energy to the cardiac tissue, so it minimizes hemolysis, micro-bubbles, thermal effects, and skeletal muscle stimulation. The design is a prospective single-arm study at 38 sites worldwide. Enrolled 392 subjects that are symptomatic, recurrent, persistent, or paroxysmal atrial fibrillation. And it's important that this population is studied in the persistent population as well. And the primary endpoints is a seven-day safety and 12-month long effectiveness data. The procedure workflow, basically before the ablation, we do a mapping with the HD grid. We pace for phrenic nerve, and tag where the nerve is, and where we have capture. And then we deliver using the design, the requirement is if it's a nominal setting, then two applications per vein, at least two applications per vein. Or if it's a, if we have phrenic nerve capture, then we dial it down to the low waveform, and then it has to be three delivery per vein. The maximal of eight applications per vein. And after the ablation, there's a 20-minute wait period. Then we assess the voltage again, assess for entrance block with phrenic nerve pacing, and also pericardial effusion assessment. The long-term follow-up is ongoing, and there will be entire rhythmic assessment, drug assessment, are they still on the same medication, or escalation of medication, discontinuation of the medication. And the rhythm assessment is using ECG, TTM, Holter monitor, and also quality of life questionnaire. The study population, 392 subjects were enrolled, worldwide 38 sites. The enrollment was very fast, between, it started in April last year, and finished very quickly in September. The subjects underwent PBI only, 374 subjects. There were 52 roll-in periods, so the first time use in the physicians, those are roll-ins, so 320 were assessed in the primary analysis. And again, very importantly, there were about half and half of paroxysmal population, and persistent population. So you can see the baseline characteristics were pretty similar in terms of age, gender, BMI, but it's expected that left atrial diameter is a little bit larger in the persistent population, and also they were on antiarrhythmic at the time of the procedure. The acute effectiveness was defined as entrance block after 20 minutes wait period, after a maximal of eight PFA applications per the design. And in both paroxysmal and persistent AFib, greater than 99% acute effectiveness was achieved. In the paroxysmal AFib group, 98% subjects, in persistent AFib group, 99% subjects. In the applications was on average 17 applications pervading the paroxysmal, and 19 in the paroxysmal AFib group. The safety data also is 1.9% primary safety events was seen, and this was lower, or even equivalent with other technologies. There were two cardiac tympanod, one pericarditis, one stroke, one vascular access complication, and one prolonged hospitalization. Of note, there was no esophageal or phrenic nerve injury, no pulmonary venous stenosis or coronary artery spasm. And again, the balloon directs the energy towards the cardiac tissue, so it minimizes this energy wasting in the blood pool, so it minimizes the risk of hemolysis and renal adverse events. So 0% of the study subject had hemolysis or renal adverse events. Certain sites, it was their standard of practice to obtain labs and biomarkers before and after the procedure, and the biomarkers were not significantly different. There was a slight drop in the hemoglobin, hematocrit likely just from the procedure with aspiration in the 13 French sheep. There were several workflows, different workflows that were done in different sites, so we were able to take advantage of that, and so the Volt can be applied in different workflows. So you can see that in the ice, you can visualize in ice, you can visualize it via fluoroscopy by filling with nine cc's of saline and one cc of contrast, and you can use the guide wire to rail the balloon in, or you could just deflect the balloon on its own, so there are different workflows. The transpired ablation time was 35 minutes, and again, total PFA application was about 18 per subject, so around four to five applications per vein. And very importantly is that, because there was not a lot of muscle stimulation or skeletal muscle stimulation or cough, sedation, light sedation could be used. So in 56 people, subjects, so 17.7% did not use GA, and out of those, 20 of them did not use propofol, silverset, and fentanyl were in use, and there was not a significant difference between the acute effectiveness or safety among this, so this could be applied. Without general anesthesia. And also, again, the fluoroscopy data, there's not a big difference. You can use fluoroscopy versus zero fluoro, and there's not a significant difference in acute effectiveness or safety. So in conclusion, 320 subjects underwent the full PFA system ablation, about half and half paroxysmal and persistent AFib in different types of workflow, light sedation, zero fluoro, and we achieved acute effectiveness of greater than 99% in acute safety event rate of 1.9%. These results demonstrate acute safety and effectiveness of the full PFA system for treatment of paroxysmal and persistent atrial fibrillation and the 12-month follow-up is ongoing. And I want to thank the co-investigators and these different centers worldwide and the Abbott study team. And I'm happy to announce that this data can be seen, can be obtained as there's a simultaneous publication in Heart Rhythm, and you can get more information here. Thanks. Thank you. Thank you for allowing me to comment on this very nicely done study. Okay, there are my disclosures. There are my disclosures. First of all, I'd like to congratulate Monica and her co-investigators on completing this trial. You know, it's always difficult to complete a multi-center, especially an IDE trial. So congratulations, and look at the time they did it in six months. Quite a feat. You know, some of the notable observations that I liked about this study was it's a single-shot device, very efficient. It looked at least acutely excellent, acute pulmonary vein isolation, and also very acceptable primary safety profile. You know, the one thing I did note is that two of the complications were tamponade and perforation. So I think, you know, as we gain more experience, that is something that we should watch. And it's probably just training. And I would expect that that would not be an issue. You know, the nice thing about this is that, you know, it finally integrates mapping, and the impedance-based assessment of tissue contact gets us back to the ability to go floral-lessly. You know, you think about it, you know, a couple of years ago, before PFA, the goal was to do everything floral-lessly. Then all of a sudden, PFA came, and we went back to floral. So, you know, off with the lead, you know, so I do appreciate that. You know, and then the occlusion balloon with increased tissue contact, which may limit hemolysis. You know, Monica already alluded to some of the salient features. You know, but having a balloon in there occluding the vein, you have less opposition to the blood, and then also the balloon itself may shield some of the electrodes. So, you know, I think that is an advantage. However, you know, when you're actually doing just pulmonary vein isolation, theoretically, you know, you shouldn't have any clinically significant hemolysis. You know, and that actually goes to, you know, this seems to be a very effective device for pulmonary vein isolation, but it may be limited to pulmonary vein isolation. And the reason why I say that is is that we have to take this into consideration with the other tools available. And if you have a strategy to go beyond the pulmonary veins, you may choose another device. And then lastly, you know, this was a very healthy AF population. And even in the patients with persistent atrial fibrillation, you know, their atria was minimally enlarged. So, you know, we have to, you know, I'm looking forward to the long-term efficacy data, but you would expect that the success rates should be relatively good. So in conclusion, really, the acute results of the VOLT AF-IDE trial demonstrate a safe and effective balloon-based PFA device for pulmonary vein isolation. And looking forward to the 12-month data, and we may get a glimpse of that later in the session by Prosh Sanders. Thank you very much. As we're short on time, I'll just ask one quick question, Monica. Did you have any experience with your cohort or your study population of any atypical PV anatomy, like more proximal branches, particularly large single ostium, and any issues with using the VOLT in that kind of anatomy? So I typically get a CTA beforehand to try to help me define the anatomy. And there was probably about four to five initial cases of trying to get into, everybody talks about the RIPV, but the learning curve isn't that steep. So typically, after you can, initially I was looking at how to do the transeptal so that I could get into the veins pretty easily, but I did use the wire technique where I use the agilis, push the wire out, and then leave with the balloon. Again, there are different ways to do it. There are people that just manipulate with just the balloon deflection. So again, the learning curve isn't that tough, and it didn't seem like it was tough to get into certain veins, but the CTs did help me plan for the procedure and look at variant anatomies. Did you exclude any patients on the basis of their anatomy? I did not, I did not. So it was pretty user-friendly. Perfect. In the interest of time, we're gonna be moving on. So I'm gonna invite Dr. Vivek Reddy to present his study on one-year outcomes of a conformal single-shot pulse-field ablation catheter for the treatment of PAS. Vivek? Am I blind? Oh, there, I am blind. Okay. Well, we may actually have time for maybe another question or two. So perhaps if you'd like to. So whenever Star Wars film ends, we'll get started. I'm really happy to present the one-year results of the SPHERE trial. This is a first-in-human trial that was conducted in Europe at three centers. So again, these are my co-investigators. And again, I'm really happy to be able to present these data. These are my own disclosures as relevant to this particular presentation in yellow. And please note, this device does not have regulatory approval anywhere in the world. The device that was studied is this conformal pulse-field ablation catheter. It's a large lattice catheter. The idea is to position the catheter within each pulmonary vein four different locations and deliver the energy. There's no rotation required. It's a conformable lattice. And the idea is that you can hopefully get good contact with the tissue. And the energy is delivered from the whole lattice. In addition, there are six bi-pole pairs, very small electrodes that you could just make out here to record electrogram activity. There are two electromagnetic sensors for localization. So the system knows where those two sensors are and extrapolates the shape of the device itself. There are six sections represented here. And each of those are sequentially energized in order to ablate the tissue. And it is a shape-adapting design. There's an actuator on the handle that you can change the shape from more linear to a sphere to this sort of pancake configuration. And the waveform is a monopolar biphasic waveform delivered over approximately six seconds. And this is delivered through a conventional eight-and-a-half-french deflectible sheath. In the interest of time, I'm not going to play a video, but you get the idea. The system is very integrated with the Afera electro-atomical mapping system. These green tags represent the casts of where the lesions were delivered. You can see sort of a shell of the anatomy that was created with this catheter itself. So here's the trial itself. The goal was to evaluate the safety and efficacy of this technology. The patients underwent an index procedure. These are paroxysmal patients. Each vein, the goal was to deliver four applications. And at approximately 75 days, there was an invasive remapping that was planned. Here's the follow-up. You can see the trans-telephonic monitors. You see the 24-hour monitor, 24-hour Holter is done in six months and in 12 months. And importantly, a subset, 15 of the 100 patients, received implantable loop recorders so we'll have continuous monitoring data. And I should note that for the primary efficacy analysis that you're going to see, these 15 patients, we simulated both the trans-telephonics and the 24-hour Holters, okay? But in addition, I'll show you the full data of those 15 patients and the outcomes using all of the electrogram data. The primary endpoints were fairly vanilla. It was acute isolation and safety. But it's the secondary endpoints that are more interesting. The 12-month chronic freedom from atrial arrhythmia recurrence and certainly the lesion durability data. So 100 patients and we'll separate them into three cohorts because the waveform did evolve. But note that the final waveform, the Pulse 3, represents about half the cohort, 50 patients out of 100. You can see in terms of remapping, the 80% of these Pulse 3 patients did undergo remapping and you see the numbers for the other cohorts. And all the patients have completed one year follow-up. And you see that, oh, I'm sorry, you see that the compliance for both the trans-telephonics and the Holters was quite good. So let's look at who these patients are. Again, this is the paroxysmal population, not surprisingly. The mean age was 58, 40% were female. You can see the left atrial dimension, mean of 4.1 centimeters and the ejection fraction was preserved. The CHA2DS2-VASc was the mean of 1.8 and the major comorbidity being hypertension. You can see all the patients have failed a class one or class three antiarrhythmic drug. The procedure time was approximately one hour and the fluoroscopy time of 6.8 minutes. And I should note that a subset of the patients, small subset, but a subset, did undergo the procedure with a completely fluoroless approach using ice only. Left atrial dwell time was 22 minutes. An impressive transpired ablation time was only 11 minutes with, you can see the standard deviations so some were clearly under 10 minutes. And the mean of four applications were delivered per pulmonary vein. So the primary safety endpoint, importantly there were no safety events in this particular study, at least primary safety events. There was one patient that had diplopia and vertigo. This was consistent with the sort of migraine-like effects that we sometimes see with these procedures. There was a esophageal sub-study. There were no thermal injuries. The brain sub-study, you can see four patients had flare positivity, about 10%, which I think is consistent with what we see with most procedures. So what does it look like? This is the pre-ablation electron topical map. This is the post-ablation map. You see where the tags were, where the lesions were delivered in the low voltage. And you see in this particular patient that had a 75-day remap, the approximate location of the low voltage. So what is the durability data? Well, here it is. If we look on a per vein basis, and I'll just ask you to concentrate on the blue, well, they're both blue, on the dark blue graph. So this is the most recent waveform, the pulse three waveform and you can see the per vein durability was 98%. And that translated to a per patient durability of 93%. So that means there were only three reconnected veins with the pulse three waveform. We can look at these three reconnected veins. I think it is interesting. If you look at these three veins, and these are actually the three patients, it turns out they all happened in the left superior pulmonary vein. There were four gaps in three veins. And interestingly, they all occurred in sort of the anterior superior aspect of the left superior pulmonary vein. Now, why might that be? Well, it might be because as we know, the left superior pulmonary vein sort of dives or moves anteriorly from the left atrial body. So you wonder if when positioning the basket catheter, the conformable basket, perhaps we should put it a little bit further inside the left superior to get better investiture in contact with the tissue. Again, that's hypothesis, but certainly in future trials, it'd be interesting to spend a little more time, maybe one extra lesion in the left superior. If we look at the effectiveness, acute success is 100%, not a big surprise. But if you look at the 12-month success, you can see in the full cohort, and importantly, the pulse-free cohort, a success of 88%. Now, again, this is 85 patients using the Holter monitors and 15 patients using simulated Holter data from the implantable loop recorder. What about those 15 patients? Well, if you look at that 15-patient ILR sub-cohort, all of whom, by the way, received the pulse-free waveform, only three patients had recurrences. So 80% freedom from all atrial arrhythmias. This is, again, using all data. Interestingly, if you look at those three specific patients that had recurrence and look at their daily AF burden before ablation versus after ablation, you can see there's a significant decrease in AF burden, as well, it's the same number, but anyway, significant decrease in total time patients spent per day in atrial fibrillation. So all the patients seem to benefit. So in this first-in-human European study, I think what we observed was that this conformable catheter was efficient, it was safe, and it was effective, and it has a relatively predictable workflow with a mean of four applications per vein. There were no safety events, no primary safety events, and if you look at the durability data, I think it's quite good, 98% on a per vein basis is, I think, very impressive. If you look at freedom from atrial arrhythmias, it was quite good, about 80%, even when using continuous monitoring. And importantly, and hopefully, the FDA pivotal trial with this technology here in the United States will hopefully start later this year. Thank you very much. To deliver the commentary, Dr. Michael Hoskins from New Mexico Heart Institute. Thank you. I want to thank the abstract committee for allowing me to participate and. I want to congratulate the authors on a terrific study. First in human, 100 patients, and these are my disclosures. So let's go through some of the key findings from the SPHERE 360 clinical study. We'll first start with the catheter features. This catheter has all the usual features that you would want in a single catheter approach to AFib ablation. It has the ability for mapping ablation, has an impedance-based tissue proximity metric, and a single-sized catheter with an adjustable shape to allow you to conform to different pulmonary vein anatomies. Remember, when we're doing these studies, we're evaluating the catheter and the energy source. And in this case, this is a monopolar energy source, biphasic pulse field ablation. The patients were all paroxysmal and drug refractory. They, in general, had no significant heart disease. They were fairly healthy patients with a low CHA2DS2-VASc score, which makes them ideal candidates to undergo this type of catheter ablation for AFib. From a procedural standpoint, they had very short procedural times and very short left atrial dwell times, keeping in mind that this was pulmonary vein isolation strategy only. And we do wonder what the use of this catheter in other areas of the left atrium would be. It seems like it may be suitable for some additional ablation techniques. From the result standpoint, they had excellent durability at 75-day remapping, with only three reconnections out of over 150 individual pulmonary veins. That's pretty remarkable. And it is interesting, as Dr. Reddy mentioned, that these reconnections were isolated to a very specific and limited anatomic region. Why that is, I don't think we know the full answer yet. The freedom from arrhythmia recurrence data was excellent, and I really appreciate the fact that they had the binary, any recurrence, yes or no, but also the total arrhythmia burden and comparing the pre- and post-ablation arrhythmia burden with the implantable loop recorders is really important from a patient standpoint. If I'm a patient getting an AFib ablation, this is the most important part of this trial. Zero adverse events related to the ablation procedure. That's pretty remarkable. Noting that, again, this is pulmonary vein isolation only. We've seen cases where expanding the ablation strategy may increase risks, and we don't know the answer using this tool. In conclusion, I think the keys for successful clinical use for a catheter such as this, you need effective acute results, which they showed, need excellent durability at 75 days, which showed superb safety data, and then once it's released and gets in the hands of the general population, you really need this to be easily usable by the general EP community, and we anticipate that that would be the case. Thank you. We're already running over time, so we're going to keep going. Fantastic. So I invite Dr. Wenzhen Chen from Nanjing Drum Tower Hospital Group, and he'll be speaking to us today about pulmonary vein isolation combined with isolation of the superior vena cava versus pulmonary vein isolation alone in Parix's malatrial fibrillation, a randomized controlled trial. Thank you. Good afternoon, everyone. It is my pleasure to stand here to share results from our clinical trial comparing the pulmonary vein isolation plus the empiric SVC isolation to the pulmonary vein isolation alone in paroxysmal atrial fibrillation. As we know, this is actually we think is an older topic. Our study was conducted across eight hospitals in mainland China. And this is our study background. As we know, embryologically, a kind to the pulmonary veins, SVC contains myocardial sleeves. And it has been identified as a frequent trigger site. And so SVC isolation has been proposed as a strategy to mitigate atrial fibrillation recurrence. But routine incorporation of the SVC isolation into the treatment strategy of the paroxysmal atrial fibrillation remains a controversy. So we did this prospective randomized multi-center trial. Our patients were randomized assigned in one-to-one ratio to either the study group or the control group. And we started our clinical trial in 2021. And we completed our study nearly 40 months. And this is our study flow chart. And we used after three months blank period. After three and six months of follow-up, we used 21-day auto-motoring. And one year, we used three days to follow up. And after that, we followed up every six months after. And this is our study's primary and second endpoint. And the primary point is the freedom from the documented atrial arrhythmia lasted more than 30 seconds following a single operation procedure. And the secondary endpoints are as follows. One is freedom in the subgroup defined atrial sex and hypertension, CAD, BMI, and the left atrium diameter. And number two is the procedure characteristics, like the procedure time, flow time, and application time. Three is the safety outcome. For the inclusion criteria and the actual inclusion, there's nothing very important to highlight. And let's move to the enrollment and the flow charts. We screened 309 patients with atrial fibrillation. And seven patients excluded. Finally, 302 patients randomized into the two groups. Each group included 151 patients. And all the patients received intervention. And seven patients lost to follow-up in the study group. And nine patients lost to follow-up in the control group. But all of the patients completed the follow-up the three-month blank period. So totally, all of the patients get included in the primary analysis. So this is our patient's baseline. So there's nothing very important to point out. So let's move to our outcomes. After meeting for up to 20 months, in the study group, just 20 patients experienced that recurrence. And in the PYI alone group, just 29 patients experienced recurrence. But for the procedure time, it's comparable. What I want to point out is that in subgroup of the women, recurrence rate is higher in PYI alone group. But it's lower in the plus, as with isolation. And just one patient experienced frenetic nerve paralysis, which fully recovered within six months. This is our study, Kaplan-Meier and subgroup analyzing. As I said before, in blue line is the PYI plus, as with isolation. And red line is PYI alone. So we can conclude there's no significant difference between the two groups. And as I said before, in subgroup of the women, we get the higher recurrence in the PYI alone. The P value is 0.055. So we want to make a conclusion about our study. Among the patients with paroxysmal atrial fibrillation, the addition of the empiric SVC isolation to PYI compared to the PYI alone did not significantly improve freedom from the atrial arrhythmia recurrence. And the subgroup analysis show us that observed a trend of the potential benefit of the SVC isolation in female patients. So for this study, we want to point out that the present findings do not support routine SVC isolation for the treatment of the patients with paroxysmal atrial fibrillation. Finally, our study has some of the limitations. One of the most important is that we did use the invasive recourse to follow up. So there is an estimation of the true incidence of recurrence of atrial arrhythmia, especially on the low-porting asymptomatic recurrences. And number two is maybe it's longer than that many small clinical trials. Our study may not be sufficient to capture very late recurrences driven by SVC treatment. So finally, our study sympathizes potentially underestimates its role in a subset of the patients who may benefit from SVC isolation. And finally, we want to very, very want to appreciate our study group who did a great job to create the contribution to this study. Thank you for your attention. Wonderful. I'd like to invite Dr. Ricardo Capato to give our commentary from IRCCS Multimedical Medica Group. Mr. and Mr. Chairman, ladies and gentlemen, Dr. Shen, you and your team should be congratulated for an important aspect. You helped us to get away from technology for one minute and bring us back to where things happen. And you should also be congratulated for the diligence of the design that you have performed. This goes back to an old evidence from an anecdotical report showing that elimination and isolation of the superior vena cava was successful in anecdotical reports. I also would like to be less pessimistic in terms of outcome of the study. You know, this is a well-conducted study on a limited number of subjects according to a probabilistic hypothesis. The reason why we isolate pulmonary veins is because we are unable to pick up the critical part of atrial fibrillation in the individual patients. And we assume that a given proportion of episodes are originating from the pulmonary veins. Now, the superior vena cava very nicely reflects a possible complementary substrate to give us the opportunity with the same methodology to segregate areas of potential initiation. And I think that because of the limited population and the limited time, we may not be able to explore the world potential of increasing the probability of success of this additional lesion. Although the curves, not unexpectedly, are going in different directions. In other words, and I want to conclude here, it is the limitation of any trial to have a follow-up upper limit at which we need to close the trial, perform our statistical analysis, and be limited by the economics associated with the number of patients that we can include. But certainly I go back home with the feeling that given the safety of adding SVC isolation to the PV isolation strategy, we may on a larger scale and consistent with the probabilistic hypothesis that we are applying to every ablation procedure, come up with a larger proportion of patients being fixed in the paroxysmal atrial fibrillation subcategory. So thank you very much. Thank you. All right. We're going to keep moving on. I'm going to invite next Dr. Ante Anic from the University Hospital Center in Split, Croatia. And he's going to present to us the study on coherent signburst electroporation system first in human study in patients with atrial fibrillation, the results of the BIRST-AF. Ante? Thank you. So I'm giving this opportunity to present on behalf of BIRST-AF investigators. So the Argometa PFA platform consists of proprietary generator and proprietary catheter. The generator itself is capable of, is very versatile. It's capable of doing bipolar, unipolar PFA, and it can also deliver, in the same application, you can wobble between the two to take the best out of it. I'll show you again. And there are some other improvements in the generator that are currently underway. The catheter itself is very flexible, eight electrode structure, and it is driven by stellate. What does that mean? So first let's say that we want to do PVI, then you insert this circular stellate, and you get circular catheter, which is a reasonably good tool for PVI. And then let's say that you want to do more, let's say you want linear ablation to tackle some organized arrhythmias, then you extract this linear circular stellate without the need to extract it out of your sheet. And then you get steerable catheter. So this is how it looks. So for PVI, usually we rotate this circular catheter in a PV antrum, and currently we do six applications per left-sided veins, seven applications per right-sided veins. But then later on you can choose whatever you like, and this is versatility. This platform really pays off. You can choose whatever you want, and to fire, and you can use it also as a focal catheter or create long-legged lesions. Again, as I said, you can deliver unipolar lesion, bipolar lesion, and also we can get best out of two worlds to get the depth that you get with unipolar, to get the width you get with bipolar, and improve the outcomes. BIRSA-F was a typical, first-in-human, early clinical safety and feasibility trial performed in four centers so far. Paroxysmal and precisely ablation was included. And the secret ingredient was a prospective invasive remap. This is a crucial part of development of any good PFA platform. So patients were scheduled for remap despite irrespective of arrhythmia recurrence. I'm presenting your data on first 90 patients that are included here, fair amount of persistent population, and most of the procedures are performed in deep sedation. This is very important. Preliminary results, safety assessments. No PV stenosis, as you would expect. In series of 20 paroxysmal patients who underwent pre- and post-MRI, core lab adjudicated that there are zero out of 20 with SC, SCL. No clinical apparent coronary spasm, but with nitro pretreatment. No phrenic damage, no phrenic analysis. No isogeal damage. No conduction system disorders. But, however, and this is my blame, I'm to blame. I pushed company a lot. I pushed team a lot. We didn't want to see less than 95% of the isolated PVs. And because of that, we bumped to the case where we had to do PVI, posterior wall, mitral line, focal ablation anterior, anterior left atrium, and CTI eventually, the protocol. And we bumped to hemodialysis. And this patient ended up in renal hemodialysis. And then we had two additional serious events. One was a hospitalization due to essentially panic attack. And one was just a COVID infection. However, when we bumped to the first case of hemodialysis, then I said, okay, now let's go, let's do the usual way. Let's do the, so we lowered the number of applications dramatically. We lowered by 50% the number of, the number, the energy delivery. So out of 90 patients, this was the only one patient that we didn't remap. 89 patients out of 90 came for remap. And now we started gradually understanding what is the best workflow, what is the best energy, safe for the blood, good for the durability. And with the latest iteration, we came up with close to 100% of durable lesion set. It's interesting that across all cohorts in CTI, which was easy to visualize where you're delivering under ice, we had 100% CTI durable block in all cohorts. Predilection sites were anterior, left inferior, and anterior part of right inferior. Again, as we lowered our energy, obviously it's less forgiving for a lack of ideal contact. And this is how it compares with other systems. So here we ended up with an optimized cohort close to 100% durability for PBI. And this translates, of course, in a paraximal population in close to 90%. effects with this lesion set that is durable and PFA in our persistent population. I would conclude that this is a rather simple technology, rather simple platform. However, it is not seamlessly integrated as of this moment. It's not seamlessly integrated in a system. It's evaluated in both population, personal and persistent. It's very effective and very efficacious. So currently, nominal dose means with 30 seconds per application. And with six applications for left-sided veins, seven for right-sided, it takes around 18 minutes for the PBI time, 13 or 14 minutes on the GA. And then it's a single-character solution, and you can go on, and if you observe the live case, it took two minutes in the live case to isolate posterior wall, and it took single-application CTI to block it. It's accepted, this paper is accepted for publication and expected anytime soon online in a heart rhythm. The next stage is ventricle. Just observe that what this sine wave technology can do. So we can do down to 20 millimeter depth, but still staying contained into the small width. You don't need 30 millimeter lesion width when you go down to ventricle. Thank you. Good afternoon, everybody. So today it's my pleasure to join you in this session and This system introduces two innovations that make this distinct. The first is the sine wave electroporation instead of the traditional square wave pulse, potentially allowing a smoother energy delivery and less collateral injury. Second, it's built around a versatile catheter which is capable of circular, linear and focal ablations and it streamlines procedural workflow significantly. So the goal is to have energy delivery which is simpler and potentially safer. So the early results were extremely encouraging. So in the final reflections, it appears to be a safe and effective non-thermal atherial ablation system using a versatile single catheter, potentially reducing costs and complexity. It appears to be a promising new option in our PFA landscape. So seeing that, it is an initial feasibility trial, small, non-randomized. And to have a place, a position in our pulse field landscape, I think we do need a larger trial, more head-to-head. So I want to congratulate the investigators on this innovative and promising early experience. Thank you. Wonderful. And our last presentation today will be Dr. Prash Sanders from the Royal Adelaide Hospital. And he'll speak about long-term safety and effectiveness of balloon-based PFA system for de novo PVI to treat paroxysmal atrial fibrillation and persistent atrial fibrillation results from the Volt CE Mark study. Thank you. So we heard already about the IDE study results, the acute results. And here, I'm going to be presenting the CE Marks study results on behalf of the investigators in that study. These are my disclosures. And obviously, this study is funded by Abbott. So this is the second-generation PFA system. It's a Volt system. It's a balloon-in-basket catheter over the wire introduced through a 13-French Agilis sheath that allows us to integrate it with the InsightX platform to not only create geometry, but also to get voltage activation data, visualize the catheter, and also allow us to visualize the contiguous lesions in order to isolate the pulmonary veins. It's connected to the Volt PFA generator. And one of the features I want to show you there is actually the fact that you have a nearness to surface contact assessment to guide the ablation technique. So the Volt CE Mark study is a pre-market prospective single-arm study that was done in 11 sites around the world. It enrolled 150 patients with de novo ablation of symptomatic paroxysmal or persistent atrial fibrillation. And the primary endpoints here was seven-day safety and also the acute effectiveness. And now we're presenting the long-term effectiveness of this data. It was a pulmonary vein isolation-only strategy. And any patient who required a flutter ablation was excluded from the study. This shows the follow-up of the study. The safety data that was presented is over the entire study duration. For the efficacy data, it's a blanking period of three months after which the effectiveness was assessed. This was done by clinical evaluation, ECGs, trans-telephonic monitoring biweekly or if symptomatic, 24-hour Holter monitors at six and 12 months. And we also assessed quality of life by the AFEQT questionnaire. In those patients who were undergoing clinically indicated repeat procedures, electroanatomic maps were created, and assessment of PVI durability was assessed. Shown here is data that has been presented already. It shows the acute safety and effectiveness data. The success rate of isolating the pulmonary veins was 99.1%. It's noted there's five veins that were listed there. This was after a 20-minute waiting period. And four of those veins were due to the one case of tamponade that occurred that could not allow the 20-minute waiting period. The last case that was not isolated was a patient who the operator exhausted the maximum eight pre-specified applications before doing a remap and identifying the gap and was not allowed to isolate the vein. The effective success at a subject level is 98.6%. The first pass isolation was 97.6%. The primary safety endpoints was one tamponade, two vascular events, and one case of pneumonia. That's a 2.7% incidence in this series. Now previously presented also is the subset of patients that underwent assessment of hemolysis. There was no evidence of hemolysis or of renal dysfunction in this study. And this is previously being presented. Shown here is the data in terms of the 12-month success rate in this series. In the 103 patients with paroxysmal AF, it was 83.5% after 12 months. And in a smaller group of patients with persistent atrial fibrillation, 43 patients, it was 58.1%. Knowing that this is a symptomatic recurrence or detection of asymptomatic arrhythmia of any atrial arrhythmia. In terms of quality of life assessment, you see the significant improvement in the AFEQT score immediately at three months and persists out to 12 months in this study. There were eight patients who underwent repeat procedure. Note that is symptomatic enough to undertake repeat procedure. That means the clinical success in this case is 94.5%. Of those eight patients, 27 out of the 30 pulmonary veins remained durably isolated on reassessment. That is a durable isolation of 90%. Shown is an example of one of the isolated cases. You see before ablation, immediately after. And importantly, when we go back, we don't see any regression of the electroporated region, suggesting that there's no reversible electroporation that's seen during that first case in this series. Now an exploratory hypothesis generating analysis is the number of applications that were undertaken. 17.6 per patient in the study. That's 4.7 per pulmonary vein. The study allowed two to eight applications. And it was up to the investigator as to how many they used. And one of the exploratory things here was, if you used less than, between three and five, we found that there was a trend to a difference between the recovery in these pulmonary veins. The numbers are small here, and therefore. that was undertaken. So where to from here? This is demonstrated in a robust way what a pulmonary vein isolation only strategy gets in terms of success. Very high success in paroxysmal atrial fibrillation and alerting us to the fact that with durable pulmonary vein isolation in the high-risk group, the recurrent arrhythmia group, we're seeing a recurrence rate outside of the pulmonary veins. And it raises the future studies, you know, what do we do after pulmonary vein isolation? What are the workflows? How many PF applications should be done? Should we do contact thresholds and various populations that we could evaluate? There are three ongoing studies here. The IDE study, which you've heard the acute results of, which did recruit a 48% of persistent atrial fibrillation. The Vault CE Mark extension study, which is looking at ablation outside this region. You can see a couple of examples here of posterior wall isolation, but also doing a CTI ablation. And then Blast-Off, a registry that looks at a post-market surveillance office. So let me conclude. In this Vault CE Mark 12-month data, with a pulmonary vein isolation only strategy, the success rate in terms of needing recurrent procedures were very high. The durability of lesions were 90%, and the safety of the study was a 2.7% safety. In terms of actual recurrence of arrhythmia, there is a marked difference between paroxysmal and persistent AF. And in the setting where we have durable lesions, one's got to start thinking what else we need to do in the population with persistent atrial fibrillation. So let me conclude at this point by acknowledging all the investigators and the centers that participated in this study. Thank you. Super, thank you so much. And then our final commentator, Dr. Arash Aranya from Mercy General Hospital. Good afternoon, ladies and gentlemen, ladies of audience, gentlemen of the audience. I just want to first start off by congratulating Prash on his excellent trial and his co-authors. These are my disclosures. So for the last decade and a half, and until recently, single-shot balloon ablation catheters using thermal energy have been widely used. And these have been largely replaced, as I'm sure you'd agree, with some of the novel PFA technologies that we see here listed. But there are still unresolved issues with the current PFA technologies, including hemolysis, including acute kidney injury, including electrolysis, embolization, and also corny spasm. So the question that may be answered is whether a balloon and basket PFA catheter could resurrect the balloon-based ablation strategy once again. And we just heard excellent results, outcomes presented here by Prash and his colleagues that have conducted this beautiful trial. The results are certainly very impressive. The efficacy is quite good. The safety was also equally effective. And there are some potential inherent advantages to this kind of technology. Number one, it's obviously very suitable design for PBI due to its nature of this balloon and basket form. And the fact that the electrodes are at least partially insulated on the internal surface of the balloon may have implications for reduced electrolysis and also hemolysis, which does remain an Achilles heel for PFA, as I'm sure you can agree. So if we essentially think about what happens normally under normal circumstances with most PFA catheters, when we're using a non-insulated catheter, this is the scenario where you have leakage of essentially electric field into the blood pool from all angles of the electrode. Now if you can imagine, if you have a partially at least insulated electrode, you're going to be reducing that. And so there could be significant implications for safety. This is certainly consistent with some of the early data we've seen with the catheter system that we just heard about. Certainly there seems to be at least a lower detection of markers of hemolysis, such as haptoglobin and pre-plasma hemoglobin, which is I think encouraging. So I think there's more to be learned about this, but it's certainly one of the potential advantages of the system. There are, of course, as with anything else, some potential disadvantages as well. One of the things that stands out, to me at least, is the fact that the balloon or the basket form is non-compliant. And there remains to be determined what can be done using this catheter with regards to extrapolmonary ablation. We're aware of some good results, early results, from Europe in terms of ablation of the posterior wall, and possibly even there may be a role for mitral isthmus. But I think ablation of certain structures, such as the cable tractors with isthmus, could be challenging in many cases. So more to be worked out there. But I want to again, once again, congratulate Prash and his team on this beautiful paper, and more to be learned. Thank you. All right, this concludes our program. I want to thank my co-chair, Dr. Pellegrini, all the presenters, and the commentators on a wonderful job. Sorry the audience, we didn't get to have too much interaction, but at least you like us for finishing on time. Take care. Enjoy the rest of the day.

Heart Rhythm Society

atrial fibrillation

ablation techniques

pulsed field ablation

VOLT-AF IDE trial

SPHERE trial

pulmonary vein isolation

superior vena cava isolation

Argometa PFA platform

clinical application